Presentation
20 Years of Prefilled Drug Delivery Technologies – Industry’s Perspective on Human Factors Engineering Application for Platform Device Combination Products
DescriptionWith the increased focus on patient centricity and prevalence of biologics in pharmaceutical pipelines, many companies are developing drug-device combination products to facilitate patient self-administration of injectable therapeutics outside a health-care setting. Often these products are commercialized in mature delivery device technologies such as prefilled syringes with needle safety devices (PFS-NSD), autoinjectors (AI), and pen injectors. These technology choices have many benefits including their ease of use, simplicity and the breadth of usability and use-safety data [1, 2].
In the past 20+ years, approximately 100 drug-device combination products have been approved in in the United States using prefilled drug delivery technologies, with the majority of products indicated for patient and lay caregiver use outside of the healthcare setting [3]. These technologies are used to deliver therapeutics for a wide range of patient populations, encompassing those with various degrees of physical, dexterity, and cognitive capabilities, education background, previous injection experience, and demographic groups, including adolescent and geriatric patients. More products in the same or similar device formats are also being evaluated in ongoing clinical trials.
Many combination product development teams today have a heightened awareness of usability and use-safety risks, and therefore have implemented thorough human factors engineering programs. Product requirements are defined prospectively, device designs are evaluated in formative usability studies, use-related risks are identified and analyzed in risk analyses and products are validated in HF Validation studies. Recognizing that mature prefilled drug delivery technologies (e.g., PFS, AI, pen injectors) have been extensively evaluated, developers bring this cross-industry and cross-product knowledge into their development programs in the form of on-market complaint analysis [4], review of publicly available SBOA content [5], and literature.
This proposed presentation focuses on offering an industry perspective on the collective body of foundational HF knowledge for the aforementioned commonly used prefilled drug delivery technologies. Using case stud(ies), we will demonstrate the similarity in the given user interfaces and use-related risk assessments to highlight the comparability of known use errors and hazardous situations. We will discuss the successful validation of these products, despite differences in instructional material, user populations and drug-specific harms. Lastly, the presenter will lead a thought-provoking discussion on how to leverage the breadth of existing human factors knowledge for these mature devices when considering the approach to right-size the human factors engineering programs for new products and application of lessons learned for a new therapeutic area. While typically a developer might leverage knowledge of a single reference product to support the justification for waiving all (or part) of their HF Validation program, we will show the aggregate of publicly available industry knowledge that can be used as a meaningful reference for a comparative analysis and assessment of use-related risk.
References:
1. Ridyard, C.H., Dawoud, D.M.M., Tuersley, L.V. et al. A Systematic Review of Patients’ Perspectives on the Subcutaneous Route of Medication Administration. Patient 9, 281–292 (2016).
2. Stevenson J, Poker R, Schoss J, Campbell M, Everitt C, Holly B, Stones N, Pettis RJ, Sanchez-Felix M. Pharmaceutical and biotech industry perspectives on optimizing patient experience and treatment adherence through subcutaneous drug delivery design. Adv Drug Deliv Rev. 2024 Jun; 209:115322.
3. Guo J, Weng J, Zhu Q, Zhou F, Chen Q, Gu X, Zhou W. A Review of Recent FDA-Approved Biologic-Device Combination Products. J Pharm Sci. 2024 Apr;113(4):866-879.
4. Gupta, S. P., & Pidgeon, A. (2016). An analytical approach to identifying potential use-related issues concerning a medical device under development. Journal of Medical Engineering & Technology, 40(3), 61–71.
5. Patel, R., Mehta, M., Dahiya, M., & Jose, V. (2021). A review of use errors reported in human factor validation studies of biological combination products. Journal of Medical Engineering & Technology, 45(7), 582–592.
In the past 20+ years, approximately 100 drug-device combination products have been approved in in the United States using prefilled drug delivery technologies, with the majority of products indicated for patient and lay caregiver use outside of the healthcare setting [3]. These technologies are used to deliver therapeutics for a wide range of patient populations, encompassing those with various degrees of physical, dexterity, and cognitive capabilities, education background, previous injection experience, and demographic groups, including adolescent and geriatric patients. More products in the same or similar device formats are also being evaluated in ongoing clinical trials.
Many combination product development teams today have a heightened awareness of usability and use-safety risks, and therefore have implemented thorough human factors engineering programs. Product requirements are defined prospectively, device designs are evaluated in formative usability studies, use-related risks are identified and analyzed in risk analyses and products are validated in HF Validation studies. Recognizing that mature prefilled drug delivery technologies (e.g., PFS, AI, pen injectors) have been extensively evaluated, developers bring this cross-industry and cross-product knowledge into their development programs in the form of on-market complaint analysis [4], review of publicly available SBOA content [5], and literature.
This proposed presentation focuses on offering an industry perspective on the collective body of foundational HF knowledge for the aforementioned commonly used prefilled drug delivery technologies. Using case stud(ies), we will demonstrate the similarity in the given user interfaces and use-related risk assessments to highlight the comparability of known use errors and hazardous situations. We will discuss the successful validation of these products, despite differences in instructional material, user populations and drug-specific harms. Lastly, the presenter will lead a thought-provoking discussion on how to leverage the breadth of existing human factors knowledge for these mature devices when considering the approach to right-size the human factors engineering programs for new products and application of lessons learned for a new therapeutic area. While typically a developer might leverage knowledge of a single reference product to support the justification for waiving all (or part) of their HF Validation program, we will show the aggregate of publicly available industry knowledge that can be used as a meaningful reference for a comparative analysis and assessment of use-related risk.
References:
1. Ridyard, C.H., Dawoud, D.M.M., Tuersley, L.V. et al. A Systematic Review of Patients’ Perspectives on the Subcutaneous Route of Medication Administration. Patient 9, 281–292 (2016).
2. Stevenson J, Poker R, Schoss J, Campbell M, Everitt C, Holly B, Stones N, Pettis RJ, Sanchez-Felix M. Pharmaceutical and biotech industry perspectives on optimizing patient experience and treatment adherence through subcutaneous drug delivery design. Adv Drug Deliv Rev. 2024 Jun; 209:115322.
3. Guo J, Weng J, Zhu Q, Zhou F, Chen Q, Gu X, Zhou W. A Review of Recent FDA-Approved Biologic-Device Combination Products. J Pharm Sci. 2024 Apr;113(4):866-879.
4. Gupta, S. P., & Pidgeon, A. (2016). An analytical approach to identifying potential use-related issues concerning a medical device under development. Journal of Medical Engineering & Technology, 40(3), 61–71.
5. Patel, R., Mehta, M., Dahiya, M., & Jose, V. (2021). A review of use errors reported in human factor validation studies of biological combination products. Journal of Medical Engineering & Technology, 45(7), 582–592.
Event Type
Oral Presentations
TimeTuesday, April 12:15pm - 2:37pm EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)